Kornimate/medical-research-clean huggingface dataset:
clinical study, opened, of cutaneous acceptability of a topic product in normal conditions of use

Conditions: Diabetes

Summary: the measured product in this research is a product for topical use, laboratoires mercurochrome reparador e protetor. the expected benefit to the use of the product is the improvement in skin hydration as measured by self perception of participant research and clinical evaluation and improvement in local microcirculation, assessed by instrumental measurements in feet of the study participants.

the objectives of this study is to verify the skin acceptability through the non-occurrence of adverse events and cutaneous sensations of discomfort, evaluate the moisturizing efficacy of the product through self perception of research participants and dermatological clinical evaluation to assess the improvement in local microcirculation by performing of instrumental measurements in the feet of diabetic participants, product laboratoires mercurochrome repairer and protector referred by lm farma industrial ltda. for this research, will be recruited up to 35 research participants who meet the inclusion / exclusion described in items 9.4 and 9.5 of the research protocol, to achieve a number of completion of 30 participants. be recruited participants from both sexes, aged 18 and 65, which have dry skin on the feet and they are people with diabetes whose condition is stabilized.

Eligibility criteria:
inclusion criteria: * participants healthy research; * intact skin on feet - grade 0 in the wagner scale; * agreement to adhere to the procedures and requirements of the study and attend to the office (s) day (s) and time (s) set (s) for evaluations; * ability to consent to participate in writing; * age 18 to 65 years; * research participants of both sexes - including at least three men; * introducing dry skin on feet - dermatological proof. * participants with diabetes whose condition is stabilized exclusion criteria: * pregnancy and lactation; skin pathology in the product application area; * immune impairment; * current use of these medications for topical or systemic use: corticoid, immunosuppressants, antihistamines, anticoagulants or birth; * skin diseases: psoriasis, vitiligo, atopic dermatitis; * history of reaction to the category of the product tested; * other diseases or medications that may interfere directly in the study or to endanger the health of the research participant.

Keywords: diabetes skin acceptability clinical research
potential nosocomial infection prevention via modification of anesthesia intraoperative aseptic practice

Conditions: Nosocomial Infections

Summary: we hypothesized that by improving hand hygiene compliance in the operative environment, we would reduce horizontal transmission of pathogenic bacteria to surgical patients.

we performed an observational study evaluating provider adherence to these techniques. we then sought to increase hand hygiene compliance through the use of a point of care alcohol based hand hygiene device. we hypothesized that increased hand hygiene compliance would reduce bacterial contamination of the anesthesia workspace and peripheral intravenous tubing, and ultimately reducing overall morbidity and mortality secondary to a reduction in nosocomial infection rates.

Eligibility criteria:
inclusion criteria: * patients present in operating rooms randomized to study. exclusion criteria: * patients that were already enrolled in study and return to the operating room.

Keywords: anesthesia workspace hospital acquired infections hand hygiene alcohol based cleanser bacterial contamination
adolescent coordinated transition nigerian hiv+ youth

Conditions: HIV/AIDS

Summary: the purpose of this study is to evaluate the comparative effectiveness of a comprehensive, coordinated transition protocol which includes an early introduction to the adult provider, an integrated case management team and a peer-facilitated organized support group on retention in care, viral suppression and psychosocial wellbeing among adolescents living with hiv.

using a two-arm cluster randomized design, our proposed study will evaluate the comparative effectiveness of act, a coordinated protocol for transitioning adolescents living with hiv (alhiv) from pediatric to adult care (intervention group; ig) versus the usual abrupt transfer to adult care (control group; cg) on rates of retention in care and viral suppression, and differences in perceived psychosocial wellbeing. twelve health facilities, two in each of the six geopolitical zones of nigeria will be pair-matched and randomly assigned to either ig (n=6 health facilities) or cg (n=6 health facilities). a total of 216 alhiv will be enrolled in the study over a 36-month period. the primary outcome will be the difference in the rate of retention between the groups. secondary outcomes will be difference in the rate of viral suppression and the difference in perceived psychosocial wellbeing. additionally, the investigators will conduct mediation/moderation analysis to examine the role of intermediate variables such as transition readiness, perceived mental health, social support, health locus of control, self-esteem and sexual risk behavior self-efficacy on the primary outcomes. implementation factors will be assessed using the hybrid 2 model.

Eligibility criteria:
inclusion criteria: * documented hiv infection * aware of hiv diagnosis * currently on art exclusion criteria: * medically unstable

Keywords: healthcare transition adolescents nigeria
perfusion ct registry

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine whether coronary perfusion computed tomography is effective in the treatment of coronary artery disease.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 20 * patient who has a coronary perfusion computed tomography exclusion criteria: * unwillingness or inability to give informed consent

Keywords: perfusion computed tomography coronary artery disease
the effects of interrupting prolonged sitting with intermittent exercise on postprandial lipemia

Conditions: Metabolic Syndrome X; Atherosclerosis; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Disease; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Summary: the purpose of this study is to investigate the effect of interrupting prolong sedentary behavior with interval exercise on postprandial metabolism following a high fat glucose tolerance test.

all subjects complete two trials in a randomized crossover design, with each trial occurring over 4 days with a minimum of seven days between trials. the first two days of each trial serve as a control period allowing for familiarization and the control of physical activity and calorie consumption prior to the intervention. following each control period, subjects then perform one of the interventions on day 3. the interventions consist of either eight-hours of prolonged sitting, or eight hours of sitting interrupted every hour by five sprints lasting 4 seconds each using the interval exercise. on day 4, all subjects will undergo a high fat glucose tolerance test to determine the body's ability to clear triglycerides from the blood as well as insulin/glucose response and substrate oxidation. blood samples will be assayed for the previously mentioned substances and postprandial gas collection will be analyzed via indirect calorimetry.

Eligibility criteria:
inclusion criteria: - exclusion criteria: * cardiovascular problems (e.g. pre-existing heart issues, coronary artery disease, hypertension, etc.) * respiratory problems * musculoskeletal problems that prevent prolonged sitting or exercise * susceptibility to fainting * pregnancy
project mountain - comparing spo2 and sao2 for accuracy

Conditions: SpO2; Nasal Alar Collapse, Bilateral; Oxygen; Measurement

Summary: the main goal of this study is to look at the performance of the neonatal, infant, and pediatric philips spo2 sensors with the philips fast pulse oximetry technology. oxygen saturation measurements (spo2) will be obtained via pulse oximetry and invasive arterial oxygen measurements (sao2) will be obtained via arterial blood samples as part of your clinical care and assessed by co-oximetry. the study will aim to enroll a diverse population to help us understand the impact of skin pigmentation.

this is a prospective, multi-center, multi-phase, unblinded, non-randomized. self-controlled, observational study. all data analyses specified below will be calculated and summarized by each of spo2 sensors under test. demographics and baseline characteristics, including sex assigned at birth, age, ethnicity, race, baseline height, baseline weight, bmi, skin pigmentation and sensor application site measurements will be summarized with descriptive statistics using the analysis set.

Eligibility criteria:
inclusion criteria: * subject aged 18 years or older or parent/legal guardian of subject aged less than 18 years, willing and able to understand and provide written informed consent/assent. * weight and/or age within intended use of at least one spo2 sensor under test at time of enrollment. * willing and able to wear study devices in addition to soc devices and during soc procedures. * in-patient within a neonatal or pediatric intensive care unit (e.g. nicu, picu, pcicu). * has arterial access and ability to have arterial blood samples drawn as part of their soc and analyzed by co-oximetry. exclusion criteria: * known pregnancy or lactating females (self-reported) * injury, wounds, physical malformation, hyperkeratosis, or compromised/non-intact skin at sensor application site (i.e. fingers, toes, hands, feet, ears, nasal ala). note: certain malformations may be allowed if determined it would not affect application of sensor with the pulse oximetry system. * self-reported severe contact allergies to standard adhesives or other materials found in pulse oximetry sensors. note: subject may be considered eligible if subject can wear non-adhesive sensor. * unwillingness or inability to remove nail polish or artificial nails from sensor application site. * nail fungus on sensor application site. * wearing and unable to remove jewelry from sensor application site. * dye injection within 48 hours of enrollment. * known dysfunctional hemoglobin levels (cohb \>3%, methb \>2%, and cthb \<10g/dl) * undergoing phototherapy for neonatal hyperbilirubinemia during arterial blood sampling
electroacupuncture plus antiemetic therapy for chemotherapy-induced nausea and vomiting in patients with breast cancer

Conditions: Electroacupuncture; Olanzapine-contained Four-drug Antiemetic; Nausea and Vomiting

Summary: this study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (cinv) in patients with breast cancer. the research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy regimens. by investigating the synergistic potential of these modalities, the study seeks to provide insights into optimizing supportive care strategies for patients with breast cancer undergoing intensive chemotherapy treatment.

this study is a randomized controlled trial conducted in parallel groups, with blinding implemented. it aims to assess the effectiveness of combining electroacupuncture with standard quadruple antiemetic drugs for patients with breast cancer undergoing hec. both study arms will be administered olanzapine, neurokinin-1 receptor antagonists, serotonin receptor antagonists, and dexamethasone at the commencement of hec on day 1. subsequently, participants will be randomly assigned to receive either electroacupuncture or sham acupuncture. participants will be responsible for recording all instances of nausea and vomiting, as well as documenting the use of rescue antiemetic medications. the study will evaluate primary and secondary outcomes, as well as monitor adverse events.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 to 75 years, inclusive, from any nationality. 2. patients diagnosed with early-stage breast cancer. 3. eastern cooperative oncology group performance status ranging from 0 to 2. 4. all patients must undergo highly emetogenic chemotherapy (hec). 5. adequate organ function. 6. adequate contraception required for premenopausal women. exclusion criteria: 1. scheduled to undergo chemotherapy between days 2 to 4 following hec. 2. received or is planned to receive abdominal radiation therapy within 1 week before day 1 in cycle 1. 3. significant medical or psychological conditions. 4. presents with symptomatic primary or metastatic central nervous system malignancy causing nausea and/or vomiting. 5. experiencing ongoing vomiting or nausea of grade 2 or higher according to common terminology criteria for adverse events (ctcae). 6. any known allergies to the study drug, antiemetics, or dexamethasone. 7. patients who have fear of electroacupuncture stimulation or are allergic to stainless steel needles. 8. received acupuncture treatments for any conditions within 8 weeks prior to hec.

Keywords: electroacupuncture olanzapine-contained four-drug antiemetic nausea and vomiting breast cancer chemotherapy
a natural history study of biomarkers and clinical outcomes in mucopolysaccharidosis type iiia (mps iiia; sanfilippo syndrome)

Conditions: Mucopolysaccharidosis III-A

Summary: this protocol is a decentralized, single cohort, natural history and biomarker study enrolling up to 20 participants with mps iiia (sanfilippo syndrome). at least 10 participants (\~50%) must be less than four years old at the time of the parent/lar consent. the study will have a screening process and 7 study visits, e.g. home visits, that will consist of serum collection and completion of a remote assessment of the vineland adaptive behavior scales 3rd edition (vineland-3) mps iiia remains a devastating disease with a high unmet medical need. there is currently a limited number of available data to adequately characterize the progression of the disease. analysis of blood biospecimens and adaptive behavior in this study will help researchers better understand the clinical progression of mps iiia. a better understanding of disease progression may assist in developing novel therapies for rare genetic disorders.


Eligibility criteria:
inclusion criteria: * age of enrollment is as follows: 1. all participants must be between 4 months and \< 14 years at time of consent 2. at least 10 participants (ie, approx. 50% of expected total population) must be between 4 months old and \< 4 years old at the time of consent * the participant has a confirmed diagnosis of mucopolysaccharidosis type iiia (mps iiia) (i.e., sanfilippo syndrome) based on at least 2 out of the 3 following criteria: 1. documented reduced n-sulphoglucosamine sulphohydrolase (sgsh) activity in plasma, white blood cells, and/or skin fibroblasts consistent with mps iiia (10% or less of the lower limit of the normal range based on the testing laboratory) 2. documented likely pathogenic variant of the sgsh gene 3. documented elevated heparan sulfate levels in urine and/or blood participants and their families are willing to complete 7 blood draws and 7 vineland-3 collections exclusion criteria: * known history of hiv, hepatitis, or other infectious diseases * taken an investigational product in the last 30 days * experienced excess blood loss, including blood donation, defined as 80 ml in the last month or 160 ml in the previous two months * undergone an mps iiia gene therapy at any time unless prior sponsor or designee's approval has been received * documented loss of activity of sulfatases other than n-sulphoglucosamine sulphohydrolase (sgsh), indicating multiple sulfatase deficiency * known genetic or acquired disorder associated with developmental delay, seizures or other significant cns dysfunction that would be expected to confound the clinical or biomarker assessments
food is medicine: makin' healthy groceries

Conditions: Hypertension

Summary: this is a minimal risk study focusing on food purchasing and consumption in 100 subjects in the greater new orleans area. there is evidence showing that individually-targeted vouchers effectively increase category-level food purchases in both less healthful and more healthful categories. this pilot study will investigate whether a voucher program using instacart or a local, brick-and-mortar supermarket in new orleans, la lead to changes in food purchasing patterns, food consumption, food insecurity, and access to healthy food options for the participants, who are at risk of cardiovascular disease and/or cardiac complications. the study will also measure concordance between food purchasing and actual consumption.


Eligibility criteria:
inclusion criteria: * greater than or equal to 50 years of age * uncontrolled hypertension (defined as at least two clinically documented blood pressure readings of systolic bp \>= 140 and diastolic bp \>=90 in the prior 6 months) * understands english exclusion criteria: * no internet access (at home, library, relative, or though phone plan) * no adequate transportation (personal car, reliable ride, bus, and/or uber/lyft) in the new orleans area

Keywords: food insecurity food as medicine american heart association (aha) new orleans louisiana pcornet electronic health record (ehr) cardiovascular disease hypertension
physical activity, mhealth and intellectual disability - a pilot study

Conditions: Intellectual Disability

Summary: the main objective of this pilot study is to assess distant procedures, study experiences and feasibility of a planned randomized controlled trial investigating the use of a mhealth support tool on physical activity for individuals with intellectual disability.

for individuals with intellectual disability (id) with low physical activity (pa) levels, new methods to increase participation in physical activity are needed. motivation for participation in pa should include both individuals with id, family members and staff, and it should work in a supportive way to strengthen mastery experiences. technology-based interventions have not yet been explored extensively. the study objective is to assess feasibility of procedures for a distant, covid-19-secure intervention, study pre-treatment expectations and experiences of participants and their caregivers. in addition, the study will explore the effectiveness of an individually tailored pa program with motivational mobile health support on everyday levels of pa, goal setting and self-efficacy in a pa setting for youth and adults with intellectual disabilities. the current protocol concerns the conducting of a mixed method pilot study to test intervention procedures of a planned complex randomised controlled trial, with steps per day as main outcome. ten participants with intellectual disability are included. assessment are at baseline, follow-up after 4 weeks and 12 weeks. goal attainment scale will be used together with the introduction of an activity planner application named active leisure as the intervention. feasibility and acceptance of procedures, activity measures and questionnaires are assessed. the present trial will investigate how modern technology and e-health can be used in the promotion of pa in individuals with ids. the study has potentially important implications for both individuals with ids and their support networks. if successful, the project will provide a simple and accessible solution for promoting pa in individuals with ids.

Eligibility criteria:
inclusion criteria: * low physical activity levels: determined with the question "how much of your leisure time have you been physically active in the last year?" * diagnosis of intellectual disability (mild, moderate, severe, or profound) * aged 16-60 years old * ability to participate in the intervention * ability to walk with or without support * able to provide written informed consent or written informed consent can be obtained from a representative exclusion criteria: * medical contraindications for participation in programs with increased exercise, as advised by the primary care or id specialist physician * high level of physical activity * inability to provide written informed consent and written informed consent cannot be obtained from a representative

Keywords: intellectual disability physical activity technology mhealth
a safety and efficacy study of xolair in peanut allergy

Conditions: Allergy

Summary: this is a 38-week, randomized, double-blind, placebo-controlled, parallel group trial of approximately 150 patients who have a history of immediate hypersensitivity reaction to peanut protein.


Eligibility criteria:
inclusion criteria: * the patient has a diagnosis of acute peanut allergy * the patient meets the xolair dosing table eligibility criteria by having a serum baseline ige level between 30 and 1300iu/ml, and a body weight between 20 and 150 kilograms * the patient is six to 75 years of age * the patient reacts to peanut flour but not wheat (placebo) flour during the first oral food challenge (ofc) * the patient has a positive skin prick test to peanut or detectable serum peanut-specific ige level * the patient is able to swallow capsules exclusion criteria: * have fev1 value \<80% predicted or any clinical features of moderate persistent asthma, as defined by the nhlbi guidelines * have other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the investigator, make the subject unsuitable for induction of food reactions * have a history of allergy to wheat protein * have previously been exposed to monoclonal antibody treatment

Keywords: peanut
supervised manual physical therapy exercise for ankle disability after motor vehicle accidents.

Conditions: Ankle Deformity

Summary: every year more than 50 million people worldwide are injured due to rtas which in turn makes it one of the leading causes of disability. during automobile collisions, the lower limbs are the most commonly injured region of the human body. ankle injuries can be particularly long-lasting, resulting in excessive medical costs, inability to work, and serious psychological distress. physiotherapists often contribute to the rehabilitation of ankle fractures, which typically starts soon after the period of immobilization. joint mobilization led to increased ankle movement, improved gait patterns, reduced pain and the number of treatment sessions required, and hastened return to activities when compared with the usual rest, ice, compression, and elevation protocol.

participants will be assigned into two groups: 1. study group will receive a supervised physical therapy exercise program in the form of mobilization exercise, stretching exercise, and strengthening exercise. 2. control group will receive a home-based exercise program of stretching exercises, strengthening exercises and rom exercises.

Eligibility criteria:
inclusion criteria: * patients with stable ankle fractures after motor vehicle accidents involving the distal tibia, distal fibula, or talus treated with cast immobilization, with the removed cast in the preceding seven days. * approval from the orthopedic specialist to weight-bear as tolerated or partial weight-bear. -- their ages will be between the age of 18 to 50 years of age. * participants having no concurrent injuries or pathology, such as neurological injury or other fractures. exclusion criteria: * patients with surgical fixation, * fracture malunion or nonunion, * syndesmosis injury, or any standard contraindication to manual physical therapy.